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European Ombudsman
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Refusal by the EMA to public access under Regulation 1049/2001 to a long-term epidemiological study (the Santé Adulte Gh Enfant (SAGhE) study), which led the EMA to initiate a review procedure relating to growth hormone (somatropin) treatment


Case 1701/2011/ANA - Opened on Monday | 12 September 2011 - Decision on Monday | 24 June 2013 - Institution concerned European Medicines Agency ( No further inquiries justified )

Allegation(s)

EMA failed to give sufficient reasons for its refusal, on the basis of Article 4(2)(1) of Regulation 1049/2011, to grant access to the SAGhE study data. In particular, it failed (i) to establish the existence of a commercial interest which could be undermined by disclosure; (ii) to take into account the existence of an overriding public interest in disclosure; and (iii) to take into account the principle of proportionality.

Claim(s)

EMA should disclose (i) the protocols of the SAGhE study and (ii) the complete set of results from the French dataset, in line with the complainant's requests for access.